Z-1296-2022 Class II Terminated
FDA device recall Z-1296-2022 was initiated by Olympus Corporation Of The Americas on May 26, 2022 and is designated Class II. Reason for recall: Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device. The recall status is terminated (terminated Feb 5, 2025). Affected quantity: 190 cartons (950 pieces total).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- May 26, 2022
- Termination Date
- Feb 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 cartons (950 pieces total)
Product Description
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber
Reason for Recall
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Distribution Pattern
Nationwide distribution in the US. Foreign distribution worldwide.
Code Information
UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton) 00821925044043 KR197789 TFL-FBX550S (Carton) 00821925043930 KR206254 TFL-FBX200S (Carton) 00821925043930 KR206254 TFL-FBX365S (Pouch)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1296-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026